MASTIC DENT OULO ACTION- sodium fluoride paste, dentifrice 
Chia Gi LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients

Drug Facts:

Active Ingredients:

Warnings

Warnings:

Dosage

Use a pea-sized amount

Keep out of reach.

Keep out of reach of children under 6 years of age.

Directions

Directions:

Inactive Ingredients

Inactive Ingredients:

Water, Sorbitol, Hydrated Silica, Glycerine, Peg-8, Fragrance, Sodium Lauryl Sarcosinate, Xanthan Gum, Titanium Dioxide, Chamomilla Recutita, Camelia Sinensis, Menthol Crystals, Sodium Saccharin, Allantoin, Pistacia Lentiscus (Mastic) Gum, Bisabolol, Glycyrrhetinic Acid, Sodium Hydroxide

Information of owner

Product Of Chios

CHIA GI LTD

144 AG. MINA, HIOS, 82100

GREECE
Tel.: 30-22710-33101, FAX: 30-22710-32229
www.masticspa.com
Made In Greece

PURPOSE SECTION

Aids in the prevention of dental cavities

Image of Label

toothpaste box

MASTIC DENT OULO ACTION 
sodium fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:15304-4681
Route of Administration ORAL, DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 2.2 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ENOXOLONE (UNII: P540XA09DR)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ALLANTOIN (UNII: 344S277G0Z)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)  
MENTHOL (UNII: L7T10EIP3A)  
PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
.ALPHA.-BISABOLOL, ()- (UNII: 36HQN158VC)  
CHAMOMILE (UNII: FGL3685T2X)  
Product Characteristics
Color white Score     
Shape Size
Flavor MINT (Mint Flavor) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:15304-4681-1 75 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 11/22/2005
Labeler - Chia Gi LTD (363215270)
Registrant - Chia Gi LTD (363215270)
Establishment
Name Address ID/FEI Business Operations
Chia Gi LTD 363215270 manufacture(15304-4681) , label(15304-4681) , pack(15304-4681)

Revised: 12/2012
Document Id: ca4990dc-9be6-44e4-9a67-fb0eb0682b2f
Set id: fc0a1a66-84a0-4b7e-9fa6-cc82d39c9abd
Version: 1
Effective Time: 20121226
 
Chia Gi LTD